Cook Ireland, Ltd.
Cook Ireland, Ltd. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 1 FDA device recall on record.
Top product codes for Cook Ireland, Ltd.
- FGE — Gastroenterology, Urology
- FCG — Gastroenterology, Urology
- ESW — General, Plastic Surgery
- MUM — General, Plastic Surgery
- FAD — Gastroenterology, Urology
- FBK — Gastroenterology, Urology
- FDI — Gastroenterology, Urology
- FDX — Gastroenterology, Urology
- FEG — Gastroenterology, Urology
- FER — Gastroenterology, Urology
FDA recalls by Cook Ireland, Ltd.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cook Ireland, Ltd.
- K261274 — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes +1 more
- K241209 — EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
- K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS) +4 more
- K230909 — EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
- K213946 — Compass BDS Biliary Stent
- K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
- DEN180062 — EchoTip Insight Portosystemic Pressure Gradient Measuring System
- K182980 — Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
- K172057 — Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
- K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
- K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set
- K171623 — Nasal Pancreatic Drainage Set
- K163468 — Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
- K163169 — Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
- K163018 — Zilver 635 Biliary Stent
- K162717 — Evolution Esophageal Stent System Partially Covered
- K160229 — Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
- K142688 — Echotip Procore HD Ultrasound Biopsy Needle
- K122716 — PLASMATRODE SALINE SAFE TUR ELECTRODE
- K121430 — EVOLUTION BILIARY STENT SYSTEM
- K113510 — EVOLUTION COLONIC STENT SYSTEM
- K113634 — INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
- K101530 — EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
- K093619 — EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
- K093195 — ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
- K092359 — ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
- K080359 — EVOLUTION ESOPHAGEAL STENT SYSTEM
- K063742 — RESONANCE METALLIC URETERAL STENT
- K060623 — SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
- K060624 — MARATHON STENT WITH FUSION TECHNOLOGY
- K052279 — COOK IRELAND ECHOBRUSH
- K050578 — COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
- K050294 — COOK IRELAND SONNET POLYPECTOMY SNARE
Data sourced from openFDA. This site is unofficial and independent of the FDA.